MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SODIUM ELECTRODE; ELECTRODE, ION SPECIFIC, SODIUM

Catalog Number	10825468001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c (501) module serial number is (b)(6).The customer reported that qc was within specifications but had shifted slightly.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable sodium electrode result from the cobas 6000 c (501) module for one patient.The initial result was 128 mmol/l; the repeat result on another analyzer was 139 mmol/l.The initial result was repeated as it was questioned by the physician.
Additional Manufacturer Narrative
The calibration and qc were both in range prior to the event.A field service engineer (fse) determined that there was no issue found.The fse performed an overall check of the system, verified that the syringe seals were not worn, that the ion-selective electrode (ise) sipper nozzle and ise probe were clean with no bends.The sample probe was clean and not bent.The fse verified the rinse levels and that they were within the proper ranges.The gear pump was set on the high side, and the syringe tubing was in good condition without any kinks.He also inspected the electrodes, and the reference electrode had some salt buildup; it was cleaned and placed back in.For verification calibration, qc, and a 21-cup precision check were completed.The customer stated that after inspecting the tube of the sample in question, gel was sitting at an angle, and they saw a possible platelet, but were unable to remove it.The sample was respun and reran on the c501's.Additional results were not provided.The investigation determined that there was no cause found, and the instrument's performance was verified and the issue appears to be resolved.

• Brand Name: SODIUM ELECTRODE
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23088783
• Report Number: 1823260-2025-03144
• Device Sequence Number: 21459852
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10825468001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown